In the history of public health vaccines have proven to be among the most effective disease prevention tools. It is clear that in the fight against HIV that new and powerful preventive technology such as a vaccine is badly needed. Ethically, however the processes of developing a vaccine against HIV have been distinctly different from that of any previous pharmaceutical products. HIV vaccine trials can be ethically complex for a number of reasons. In 2004 the HIV I AIDS Vaccine Ethics Group undertook a research initiative that aimed to collect data from various South African stake holders of HIV vaccine trials to ascertain what they perceived as the ethical challenges related to HIV vaccine trials. A quantitative content analysis on the data from 31 semistructured interviews revealed that the ethical issue listed spontaneously by most of the respondents was that of informed consent. Further probing and discussion on informed consent identified a number of sub issues which the respondents thought would pose important challenges to HIV vaccine trials in the South African context. This study undertook to do a more in-depth qualitative analysis of the data to ascertain whether the challenges and concerns the stakeholders have are consistent with or different to those already identified in the literature and ethical guidelines on informed consent in medical research. What variables may be impacting on the position stakeholders take was also of interest. Results indicated that many concerns relating to the substantive and procedural elements of informed consent were consistent with those debated in the literature. These issues related to first person consent, the voluntariness of participants' consent, practicing cultural sensitivity, dealing with language issues, promoting and assessing understanding of material disclosed, issues around the vulnerability of .. participants, children and adolescents' capacity to consent and the role of the media. More specific to the South African context, stakeholders were concerned about the legal framework under which the trials take place, the general lack of education and training about HIV vaccine trials, a lack of communication and coordination between stakeholder groups, and the historical influences of apartheid on black South African participants' capacity to consent. The main variables that appeared to impact on the position stakeholders took related to the role the stakeholders play within the trials, the philosophical position underpinning their ethical viewpoints, stakeholders' understanding of vulnerability and capacity to consent, and how they view the universality or relativity of ethical issues. / Thesis (M.A.)-University of KwaZulu-Natal, Pietermaritzburg, 2008.

Objects of dissertation: the quality in health care inpatient institutions and health damage compensation in medical malpractice litigation cases. This work is a scientific assessment of the implementation of the patients‘ rights to quality in health care and health damage compensation in Lithuania, where the functioning of two patients' rights is assessed in a systematic and integrated manner, both in the medical and the legal aspect. Research: the modified Picker Institute‘s questionnaire was used for the scientific research of 1917 patients treated in hospitals in order to examine and assess their opinions on the quality of health care provided to them and evaluate the opportunities to realize their right to health care of good quality. The study analyzed 32 medical malpractice lawsuit cases of general jurisdiction courts in terms of the principles of health damage compensation, procedural characteristics and efficiency. Conclusions: statutory regulation of patients 'rights to quality in health care services and health damage compensation in Lithuania meets international and European patients' rights protection principles. The research showed that the vast majority of surveyed patients (nine out of ten) realized their right to quality in health care service in the hospital. However, six out of ten plaintiffs received the health damage compensation, plaintiffs were awarded only nearly a fifth of the requested overall pecuniary and non-pecuniary damages. / Disertacijos objektai: sveikatos priežiūros paslaugų kokybė stacionarinėse asmens sveikatos priežiūros įstaigose ir žalos sveikatai atlyginimas gydytojų civilinės atsakomybės bylose. Šis darbas - pacientų teisių į kokybišką sveikatos priežiūros paslaugą ir žalos sveikatai atlyginimą įgyvendinimo mokslinis vertinimas Lietuvoje. Iki šiolei paciento teisė į kokybišką sveikatos priežiūros paslaugą nacionaliniuose moksliniuose darbuose buvo analizuojama kokybės vadybos aspektu, o teisė į žalos sveikatai atlyginimą buvo vertinama pagal galiojančius teisės aktus ir Lietuvos teismų praktiką. Tai pirmasis mokslinis darbas, kuomet dviejų pacientų teisių funkcionavimas vertinamas sistemiškai ir integruotai, kartu tiek medicininiu, tiek teisiniu požiūriais. Tyrimai. Pritaikius Europos Picker instituto modifikuotą klausimyną tirta 1917 stacionarinėse asmens sveikatos priežiūros įstaigose gydytų pacientų nuomonė apie jiems suteiktų sveikatos priežiūros paslaugų kokybę ir vertintos pacientų galimybės realizuoti teisę į kokybišką sveikatos priežiūros paslaugą. Analizuotos 32 LR bendrosios kompetencijos teismų civilinės bylos dėl žalos sveikatai atlyginimo, vertinant patirtos žalos sveikatai kompensavimo principus, procesinius ypatumus bei efektyvumą, atskleidžiant probleminius paciento teisės į žalos sveikatai atlyginimą įgyvendinimo aspektus. Disertacijos išvadose konstatuojama, kad paciento teisių į kokybišką sveikatos priežiūros paslaugą ir žalos sveikatai atlyginimą įstatyminis... [toliau žr. visą tekstą]

Introduction: Stigma associated with HIV/AIDS creates a barrier to prevention, care and treatment of HIV/AIDS. It further restricts PLWHA from learning about their status, disclosing their status, adopting safe behaviour and accessing services such as antiretroviral treatment. Disclosure of HIV status and a reduction in stigma may contribute to the decrease in new HIV cases. Purpose: The purpose of the study was to develop a community-based framework that would encourage people living with HIV/AIDS to disclose their HIV status and reduce the stigma associated with the disease. Method: This study used the action research method to explore the experiences of stigma and disclosure of HIV status and to develop a community based framework with PLWHA who encouraged disclosure and promoted the reduction of stigma in a community-based setting. The research setting was Bhambayi, an informal settlement in the district of Inanda. Non-probability purposive sampling was used. In-depth interviews with PLWHA that had disclosed their HIV status and focus group discussions with family members, adult children and community members were conducted. Findings: The data was analyzed manually and the following categories and subcategories emerged. The categories were experience of disclosure, stigmatizing reactions, lifestyle changes after disclosure and supports to reduce stigma. Some of the sub-categories were ‘opens out the illness’, gossiping and pointing fingers, discrimination against PLWHA by family and community, changes in relationships, community awareness and formation of support groups. The findings revealed that PLWHA that had disclosed their HIV status had changed their lifestyles. Recommendations were made on the need for nurses to develop community engagement projects and establish partnerships in order to reach out to communities regarding HIV/AIDS. Incorporate HIV/AIDS stigma and discrimination into the current nurses’ curriculum. The need for research is expressed on the evaluation of the framework and conducting similar research in larger communities. Conclusion: PLWHA who had disclosed their HIV-status shared their experience of being HIV-positive and encouraged other people to get tested. The community-based framework to facilitate disclosure and reduce stigma among PLWHA can be operationalised in other informal community-settings. / Theses (Ph.D.)-University of KwaZulu-Natal, Durban, 2010.

The therapeutic privilege is a defence in terms of which a doctor may withhold information from a patient if disclosure of such information could harm the patient. This study explores the defence of therapeutic privilege and provides a critical evaluation. A comparative investigation is undertaken, while arguments springing from a variety of disciplines are also incorporated. A number of submissions are made for limiting the ambit of the defence. The main submission is that the therapeutic privilege should comply with all the requirements of the defence of necessity. In addition, it should contain some of the safeguards afforded to the patient by the requirements of the defence of negotiorum gestio so that therapeutic privilege is out of the question if medical treatment is administered against the patient's will, or the doctor has reason to believe (or knows) that the patient will refuse to undergo an intended intervention once properly informed. / Jurisprudence / L.L.M. (Jurisprudence)

The fastest growing field of law is undoubtedly that of Medical Law with the civil and disciplinary cases flowing from it. Globalization, international communication, development and evolution of Law as well as Medicine, cause this worldwide rising medical litigation. Humanitarian rights, post-modern scepticism and even iconoclastic attitudes contribute to this phenomenon. Medico-legal litigation and disciplinary complaints rise (in South Africa) up to 10 per cent per year. To assist the courts and legal profession, in medico-legal issues, helping the parties where the plaintiff has the burden of proof and the defendant for rebuttal, a medical expert witness must be used. The dilemmas and pitfalls arise, in that although knowledgeable medical experts could be used to guide the courts to the correct decision, the lack of a legal mind setting, court procedure and legal knowledge could affect the relevance, credibility and reliability, making the medical evidence of poor quality. The legal profession, deliberately, could “abuse” medical expert witnesses with demanding and coercion of results, which have unrealistic and unreasonable expectations. “Case building” occurs, especially in the adversarial systems of law, making the medical expert vulnerable under cross-examination, when it is shown that the witness has turned into a “hired gun” or is unfair. Thus, lacunae develop, making reasonable cases difficult and a quagmire of facts have to be evaluated for unreasonableness, credibility and appropriateness, compounded by the fact that seldom, cases are comparable. The danger is that the presiding officer could be misled and with limited medical knowledge and misplaced values, could reach the wrong findings. Several cases arguably show that this has led to wrongful outcomes and even unacceptable jurisprudence. The desire to “win” a case, can make a medical witness lose credibility and reasonableness with loss of objectivity, realism and relevance. With personality traits and subjectivity, the case becomes argumentative, obstinate and could even lead to lies. The miasmatic, hostile witness emerges, leading to embarrassing, unnecessary prolongation of court procedures. The medical expert witness should be well guided by the legal profession and well informed of the issues. Medical witnesses should have legal training and insight into the legal and court procedures. At the time of discovery of documents, via arbitration or mediation, medical experts should strive to reach consensus and then present their unified finding, helping the parties fairly and expediting the legal procedure and processes. / Private Law / LLM

Indiana University-Purdue University Indianapolis (IUPUI) / Children's and adolescents' capacity to provide valid informed consent is one of the key ethical concerns in pediatric research, and the focus of this project. The original contribution to knowledge is the advancement of both conceptual and empirical bioethical approaches to research with vulnerable populations. First, a review of adolescent vulnerability is presented to highlight the complex interplay between capacity and other forms of vulnerability. This review is offered as an interdisciplinary analysis to better understand why the study of vulnerable populations is critical to the ethical advancement of clinical research. Results from this analysis suggest the need for enhanced screening techniques as well as the utilization of specialized staff to identify and reduce the impact of different forms of vulnerability. The primary tasks of the empirical portion of the dissertation were to: (1) Adapt a validated adult competency assessment tool for clinical research, the MacArthur Competency Assessment Tool for Clinical Research, to assess the capacity of children and adolescents to consent to clinical research; (2) Identify predictors that impact children and adolescents’ capacity to provide consent to clinical research; and (3) assess differences and similarities in capacity between healthy and chronically ill children and adolescents. Overall results suggest adolescent capacity to consent to research was similar to adults, and most strongly associated with their family's socioeconomic status as well as their level of health literacy. These findings contrast starkly with the age-based criterion for providing consent currently utilized in assent and consent determinations. These findings also provide insights into ways to ethically involve youth in complex biomedical research.

Indiana University-Purdue University Indianapolis (IUPUI) / Living donors have contributed about 6,000 kidneys per year in the past 10 years, but more than 100,000 individuals are still waiting for a kidney transplant. Living kidney donors undergo a major surgical procedure without direct medical benefit to themselves, but comprehensive follow-up information on living donors’ health is unfortunately limited. Expert recommendations suggest capturing clinical information beyond traditional sources to improve surveillance of co-morbid conditions from living kidney donors. Currently the United Network for Organ Sharing is responsible for collecting and reporting follow-up data for all living donors from U.S. transplant centers. Under policy implemented in February of 2013, transplant centers must submit follow-up date for two years after donation, but current processes often yield to incomplete and untimely reporting. This dissertation uses a statewide Health Information Exchange as a new clinical data source to 1) retrospectively identify a cohort of living kidney donors, 2) understand their follow-up care patterns, and 3) observe selected clinical outcomes including hypertension, diabetes and post-donation renal function.

This dissertation examines the legal position relating to the participation of children in research, especially in HIV preventive clinical research in South Africa. HIV/AIDS presents a real threat to humanity and particularly to the welfare of children. The participation of children in this type of trials is therefore vital. Children, as vulnerable participants, must also be protected from harm resulting from research. The study also considers the nature of HIV preventive clinical research, pointing to the inconsistencies in the legislation governing children’s participation in HIV preventive vaccine trials. The dissertation concludes that the question of the participation of children in HIV preventive clinical research poses many challenges, as the position in the South African law and relevant ethical guidelines are inconsistent and contradictory. The study recommends in the final instance that the relevant statutory provisions and ethical guidelines be harmonised in order to clear up the inconsistencies. / Jurisprudence / LL.M. (Legal Aspects of HIV/AIDS)

The purpose of this thesis is to develop a comprehensive process for identifying and addressing primarily constitutional, medico-legal and liability issues, and in addition ethical, social and scientific issues related to the psychiatric and psychology professions in South Africa. In fulfilling this purpose, a comprehensive search is conducted of relevant historical, ethical, philosophical and clinical aspects pertaining to psychiatry and psychology, as well as an evaluation of the current juridical framework regarding the legal liability of the psychiatrist and psychologist balanced against the constitutional rights of the mentally disordered patient in South Africa. Recommendations are made for the establishment of any new controls needed to mitigate and prevent the exposure of mentally disordered patients, further attempting to provide specific remedies to adapt the current juridical framework in South Africa. The examination is conducted within the framework of the South African and United Kingdom's legal systems. Focus is placed on aspects of medical law, human rights law (as envisaged in the Bill of Rights in the Constitution of the Republic of South Africa, 1996), criminal law and the law of delict and, to a lesser extent, administrative law and the law of evidence. / Law / LL.D.

As a point of departure in this inherently interdisciplinary endeavour, the concept "Holistic Multidisciplinary Management" ("HMM") is introduced a.s a macrocosmic adaption of principles of project management. In line with HMM, a number of submissions regarding terminology and definitions in the interdisciplinary context of medicine (and particularly clinical psychiatry) and law, are made, and the foundations of medical malpractice are examined. Building on the various foundations laid, specific types of conduct that can constitute clinical-psychiatric malpractice, are addressed. A common theme that emerges in the various contexts covered, is that the psychiatrist must negotiate various proverbial tightropes, involving inter alia tensions between restraint and freedom, excessive and insufficient medication, becoming too involved and not being involved enough with clients, as well as client confidentiality and the duty to warn third parties. It is concluded that law and medicine. must work harmoniously together to establish appropriate balance. This can be achieved only if mutual understanding and integrated functioning are promoted and translated into practice. / Law / LL.M.